Travatan Z
(travoprost)Dosage & Administration
One drop in the affected eye(s) once daily in the evening (2)
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Travatan Z Prescribing Information
TRAVATAN Z® (travoprost ophthalmic solution) 0.004% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
The recommended dosage is one drop in the affected eye(s) once daily in the evening. TRAVATAN Z should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the IOP-lowering effect.
Reduction of the IOP starts approximately 2 hours after the first administration with maximum effect reached after 12 hours.
TRAVATAN Z may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart.
Ophthalmic solution containing travoprost 0.04 mg/mL.
Pregnancy
Risk Summary
There are no adequate and well-controlled studies in pregnant women to inform a drug-associated risk.
In animal reproduction studies, subcutaneous (SC) administration of travoprost to pregnant mice and rats throughout the period of organogenesis produced embryo-fetal lethality, spontaneous abortion, and premature delivery at potentially clinically relevant doses.
Advise pregnant women of a potential risk to a fetus. Because animal reproductive studies are not always predictive of human response, TRAVATAN Z should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the U.S. general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.
Data
Animal Data
An embryo-fetal study was conducted in pregnant rats administered travoprost once daily by SC injection from gestation day (GD) 6 to 18, to target the period of organogenesis. At 10 mcg/kg (60 times the maximum recommended human ocular dose [MRHOD], based on estimated plasma Cmax), travoprost was teratogenic in rats, evidenced by an increase in the incidence of skeletal malformations as well as external and visceral malformations, including fused sternebrae, domed head and hydrocephaly. Travoprost caused post-implantation loss at 10 mcg/kg. The no observed adverse effect level (NOAEL) for post-implantation loss was 3 mcg/kg (18 times the MRHOD, based on estimated plasma Cmax). The maternal NOAEL was 10 mcg/kg.
An embryo-fetal study was conducted in pregnant mice administered travoprost once daily by SC injection from GD 6 to 11, to target the period of organogenesis. At 1 mcg/kg (6 times the MRHOD, based on estimated plasma Cmax), travoprost caused postimplantation loss and decreased fetal weight. The NOAEL for malformations was 0.3 mcg/kg (2 times the MRHOD, based on estimated plasma Cmax). The maternal NOAEL was 1 mcg/kg.
Pre/postnatal studies were conducted in rats administered travoprost once daily by subcutaneous injection from GD 7 (early embryonic period) to postnatal Day 21 (end of lactation period). At doses of greater than or equal to 0.12 mcg/kg/day (0.7 times the MRHOD, based on estimated plasma Cmax), adverse pregnancy outcomes (embryo-fetal lethality, abortion, and early delivery), low-birth weight and developmental delays were observed. The NOAEL for adverse pregnancy outcomes, low-birth weight and developmental delay was 0.1 mcg/kg (0.6 times the MRHOD, based on estimated plasma Cmax). The NOAEL for maternal toxicity was 0.72 mcg/kg (4 times the MRHOD, based on estimated plasma Cmax).
Lactation
Risk Summary
There are no data on the effects of travoprost on the breastfed child or milk production. It is not known if travoprost is present in human milk following ophthalmic administration. A study in lactating rats demonstrated that radio-labeled travoprost and/or its metabolites were excreted in milk following subcutaneous administration.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TRAVATAN Z and any potential adverse effects on the breast-fed child from TRAVATAN Z.
Pediatric Use
Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use.
Geriatric Use
No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.
Hepatic and Renal Impairment
Travoprost ophthalmic solution 0.004% has been studied in patients with hepatic impairment and also in patients with renal impairment. No clinically relevant changes in hematology, blood chemistry, or urinalysis laboratory data were observed in these patients.
None.
Pigmentation
Travoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as travoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of travoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long-term effects of increased pigmentation are not known.
Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with TRAVATAN Z can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.
Eyelash Changes
TRAVATAN Z may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment.
Intraocular Inflammation
TRAVATAN Z should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.
Macular Edema
Macular edema, including cystoid macular edema, has been reported during treatment with travoprost ophthalmic solution. TRAVATAN Z should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.
Angle-closure, Inflammatory or Neovascular Glaucoma
TRAVATAN Z has not been evaluated for the treatment of angle-closure, inflammatory or neovascular glaucoma.
Bacterial Keratitis
There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.
Use with Contact Lenses
Contact lenses should be removed prior to instillation of TRAVATAN Z and may be reinserted 15 minutes following its administration.